drugset / Trial / NCT06719986
Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg
RandomizedCrossoverOpen-labelTreatment
Summary
The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into the nose) to healthy subjects with prior opioid exposure under steady state fentanyl concentrations (opioid agonism).
Timeline
- Start
- 2022-10-03
- Primary completion
- 2022-12-23
- Completion
- 2022-12-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nalmefene | Small molecule | 1.5 mg | Intramuscular |
| Comparator | Naloxone | Small molecule | 4 mg | Intranasal |